CN115151313A

CN115151313A - Oropharyngeal exercise devices, systems, and methods

Info

Publication number: CN115151313A
Application number: CN202180011009.0A
Authority: CN
Inventors: A·L·奥尔曼森; B·奥尔曼森; G·霍内菲尔德; Z·艾特尔; J·E·莫利托
Original assignee: Repair Sleep LLC
Current assignee: Repair Sleep LLC
Priority date: 2020-01-08
Filing date: 2021-01-08
Publication date: 2022-10-04
Also published as: WO2021142316A1; US20230330481A1; EP4087665A4; AU2021205349A1; EP4087665A1; US11724154B2; BR112022013483A2; US20210205656A1

Abstract

Various devices and systems herein include an oropharyngeal exercise device having a pump bulb with a bulb body having a flow restricting structure having a restricted configuration in which the flow restricting structure is configured to restrict a flow of fluid through a lumen such that a user must apply a force to increase the flow of the fluid. Other devices include a container and/or a cover thereof to which the bulb is attached or integrated.

Description

An oropharynx exercising device System and method

Cross Reference to Related Applications

The benefit of U.S. provisional application 62/958,668 entitled "Portable Exercise Device for exercising Muscles in the Mouth and Throat (A Convenient Wellness Device to Exercise the Muscles in the Mouth and Throat)" filed on 2020, 1, 8/35U.S. C. 119 (e), the entire contents of which are incorporated herein by reference.

Technical Field

Various embodiments herein relate to methods and systems for treating snoring and/or sleep apnea and other conditions, and more particularly to devices and methods for enhancing muscles in the mouth and throat to reduce or eliminate snoring, sleep apnea and/or other conditions.

Background

It is estimated that habitual snoring occurs in 44% of men and 28% of women in the united states. Snoring is the sound produced by the vibration of the soft tissues of the upper airway during sleep. This may negatively affect the sleeping quality of the bedroom partner, leading to embarrassment or frustration or a more severe long-term impact on the snorer.

Loud and habitual snoring can indicate Obstructive Sleep Apnea (OSA), which can disturb sleep.

Over 590 million people in the united states are diagnosed with OSA, and it is estimated that 80% of OSA patients are not diagnosed. OSA is a serious medical condition that affects daytime sleepiness and increases the likelihood of workplace accidents, co-morbidities such as heart disease and diabetes, and the chance of death.

Snoring can be caused by a number of contributing factors throughout the upper respiratory tract. The nasal cavity may become blocked, resulting in high-pitched snoring. The soft palate may relax and vibrate in the airflow. The tongue may relax, recede, and reduce the airway size, resulting in louder snoring or respiratory arrest. The pharyngeal muscles of the throat may relax and collapse, causing the airway to decrease in size, and resulting in snoring and/or cessation of breathing.

When a person gains weight, fatty tissue accumulates in the soft tissues of the tongue, soft palate, and throat. This can lead to a reduction in airway size and exacerbate snoring and apnea problems. As people age, the reflex response of the genioglossus muscle deteriorates significantly. The tongue muscles are used to move the tongue forward during inspiration to counteract the negative pressure generated. OSA is associated with a reduction in the tone of this muscle and other muscles in the mouth and throat.

Most current solutions are based on trying to reduce tissue to increase airway size, avoid doing things that relax muscles, mechanically keep the airway open, strengthen muscles, or surgically tighten or remove tissue. Each of these solutions has various drawbacks.

For example, weight loss may reduce obstructive sleep apnea, but initiating or maintaining efforts to change lifestyle, diet, and exercise over a period of time may face too great a barrier to the patient. Other treatments that are difficult for a patient to administer include alcohol and/or tobacco cessation or sleep on their side.

Another solution is a nasal dilator, which can be used to keep the nasal passages mechanically open throughout the night. Similarly, decongestants, saline nasal washes and intranasal glucocorticoids work well to keep the nasal passages from becoming occluded. However, nasal patency contributes only to one of the factors of snoring, and therefore will only work for a subset of the population.

Continuous Positive Airway Pressure (CPAP) is the gold standard for obstructive sleep apnea and is also prescribed for snoring. However, compliance rates are approximately 40%, with 20% of patients completely rejecting treatment. The device is uncomfortable, feels tethered to the hose while the patient sleeps, must be cleaned daily, is expensive, and is generally undesirable for the patient.

Oral appliances such as those used to advance the mandible are another form of treatment for patients. Problems faced with these devices may include jaw pain and long-term side effects, such as tooth movement.

Surgical methods involve surgical procedures such as uvula-palatopharynoplasty (UPPP), laser Assisted UP (LAUP), radio frequency palatal surgery, and soft palate implantation. However, these surgeries are considered very painful, they appear to have only short-term effects, and most people do not recommend them to others.

Another solution involves strengthening muscles in the mouth and throat through oropharyngeal exercises.

One drawback of these exercise regimens is the burden on the patient (including participating in a treatment session, exercising at home and performing the treatment properly on their own). In addition, people do not like to acknowledge that they have problems.

One particular method for such exercises is to play digerido. However, disadvantages include having to learn how to play the instrument and the time required to learn and then play the instrument.

Another known solution is app-based snoring exercise therapy. However, this solution is disadvantageous in that it takes 15 minutes in a person's day, it cannot be used in public places because the user has to sound, and for some people it can be considered to be repetitive after 1 week of use.

There is a need in the art for improved methods, systems, and devices for treating snoring and/or sleep apnea.

Disclosure of Invention

Various exercise devices are discussed herein that are used by a user to perform various oropharyngeal exercises, including various pump bulb embodiments and container embodiments that operate in conjunction with a pump bulb.

In example 1, an oropharyngeal exercise device includes a bulb body including a mouthpiece sized and shaped to be insertable into a mouth of a user; a proximal extension; and a central body disposed between the suction nozzle and the proximal extension. The apparatus further comprises: a lumen defined within the bulb body such that the lumen is defined within the suction nozzle, the proximal extension, and the central body; a proximal opening defined in the proximal extension, wherein the proximal opening is sized to couple with an elongate tube, whereby the proximal opening allows liquid to flow into the lumen; a flow restricting structure associated with the bulb body, wherein the flow restricting structure includes a restricted configuration in which the flow restricting structure is configured to restrict a flow of fluid through the lumen such that the user must apply at least a first amount of negative pressure to increase the flow of the fluid; and at least one distal opening defined in the suction nozzle and in fluid communication with the lumen, wherein the flow restricting structure can be the at least one distal opening.

Example 2 relates to the exercise device of example 1, wherein the mouthpiece has an oval cross-sectional shape.

Example 3 relates to the exercise device of example 1, wherein the flow restricting structure further includes an unrestricted configuration configured to allow liquid to flow through the unrestricted configuration at a rate greater than the restricted configuration, wherein the flow restricting structure is forced into the unrestricted configuration after the user has applied at least a second amount of negative pressure, wherein the second amount is greater than the first amount.

Example 4 relates to the exercise device of example 1, wherein the at least one distal opening is a slit defined in a distal end of the distal extension.

Example 5 relates to the exercise device of example 4, wherein a length of the slit is substantially parallel to a cross-sectional width of the distal extension.

Example 6 relates to the exercise device of example 4, wherein the slit includes a stress relief opening defined at each end of the slit.

Example 7 relates to the exercise device of example 1, wherein an outer diameter of the central body is greater than an outer diameter of the distal extension and the proximal extension.

Example 8 relates to the exercise device of example 1, wherein an outer diameter of the central body is less than an outer diameter of the distal extension and the proximal extension.

Example 9 relates to the exercise device of example 1, wherein an outer diameter of the central body is substantially similar to an outer diameter of the distal extension and the proximal extension.

Example 10 relates to the exercise device of example 1, wherein the flow restriction is disposed anywhere along a length of the lumen.

Example 11 relates to the exercise device of example 10, wherein the flow restricting structure includes a narrow section defined within the lumen, wherein the narrow section has a narrower diameter than any other portion of the lumen.

In example 12, an oropharyngeal exercise system includes: a liquid container; a cap removably coupled to the liquid container, the cap including a bulb receiving opening defined therein; and a pump bulb removably positioned in the bulb receiving opening. The pump bulb includes a bulb body, the bulb body includes: a suction nozzle; a proximal extension; and a central body disposed between the suction nozzle and the proximal extension, wherein an outer diameter of the central body is greater than an outer diameter of the suction nozzle and the proximal extension. Additionally, the pump bulb includes a lumen defined within the bulb body; at least one distal opening defined in a distal extension and in fluid communication with the lumen, wherein the opening is configured to restrict liquid flow out of the lumen; and a proximal opening defined in the proximal extension, wherein the proximal opening is larger than the at least one distal opening, whereby the proximal opening allows liquid to flow into the lumen.

Example 13 relates to the exercise system of example 12, wherein the center body includes an attachment structure, wherein the attachment structure is configured to be sealingly coupleable with the bulb receiving opening.

Example 14 relates to the exercise system of example 12, further comprising an elongated tube removably positioned within the proximal opening.

Example 15 relates to the exercise system of example 12, wherein the at least one distal opening is a slit defined in a distal end of the suction nozzle.

In example 16, an oropharyngeal exercise device includes a bulb body including: a distal extension; a proximal extension; and a central body disposed between the distal extension and the proximal extension. The device also includes: a lumen defined within the bulb body such that the lumen is defined within the distal extension, the proximal extension, and the central body; and at least one distal opening defined in the distal extension and in fluid communication with the lumen. The at least one distal opening includes a first restricted configuration configured to restrict liquid flow therethrough; and a second open configuration configured to allow liquid to flow therethrough at a greater rate than the first restricted configuration, wherein the at least one distal opening is forced into the second open configuration when the user has applied a predetermined amount of compressive force to the outer wall of the distal extension via the user's tongue. Additionally, the device further comprises a proximal opening defined in the proximal extension, wherein the proximal opening is larger than the at least one distal opening, whereby the proximal opening allows liquid to flow into the lumen.

Example 17 relates to the exercise device of example 16, wherein the distal extension has an oval cross-sectional shape.

Example 18 relates to the exercise device of example 16, wherein the distal extension is a mouthpiece configured to be inserted into a mouth of a user.

Example 19 relates to the exercise device of example 16, wherein the at least one distal opening is defined in a distal end of the distal extension.

Example 20 relates to the exercise device of example 16, wherein the at least one distal opening includes a plurality of distal openings.

While multiple embodiments are disclosed, other embodiments will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments. As will be realized, the various embodiments are capable of modifications in various obvious aspects, all without departing from the spirit and scope thereof. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not as restrictive.

Drawings

FIG. 1A is a perspective view of an exercise device including a liquid container and a pump bulb according to one embodiment.

FIG. 1B is an exploded perspective view of a cover and bulb of the exercise device of FIG. 1A, according to one embodiment.

FIG. 1C is a cross-sectional perspective view of a cover and bulb of the exercise device of FIG. 1A, according to one embodiment.

Fig. 2A is a perspective view of a pump bulb according to another embodiment.

FIG. 2B is another perspective view of the pump bulb of FIG. 2A, according to one embodiment.

FIG. 2C is a front view of the pump bulb of FIG. 2A, according to one embodiment.

FIG. 2D is a side view of the pump bulb of FIG. 2A, according to one embodiment.

FIG. 2E is a top view of the pump bulb of FIG. 2A, according to one embodiment.

Fig. 2F is a bottom view of the pump bulb of fig. 2A, according to one embodiment.

FIG. 3A is a diagram according to an embodiment 2A, a cross-sectional elevation view of the pump bulb.

FIG. 3B is a cross-sectional side view of the pump bulb of FIG. 2A, according to one embodiment.

FIG. 3C is a cross-sectional top view of the pump bulb of FIG. 2A, according to one embodiment.

Fig. 4A is a schematic illustration of oral exercises according to an embodiment.

Fig. 4B is a schematic illustration of another oral exercise according to an embodiment.

Fig. 4C is a schematic illustration of another oral exercise according to an embodiment.

Fig. 5A is a schematic illustration of a user performing a pumping exercise using an exercise device, according to one embodiment.

Fig. 5B is a schematic diagram of a user performing a tongue compression exercise using an exercise device, according to one embodiment.

Fig. 6 is a side view of another exercise device according to another embodiment.

FIG. 7A is a schematic illustration of a user inserting the exercise device of FIG. 6 into a user's mouth, according to one embodiment.

Fig. 7B is a schematic diagram of a user performing a pumping exercise using the exercise device of fig. 6, according to one embodiment.

FIG. 7C is a user's use of FIG. 6 according to one embodiment the exercise device of (1) performs tongue compression exercises.

Fig. 8 is a perspective view of another exercise device according to another embodiment.

FIG. 9A is a schematic illustration of a user inserting the exercise device of FIG. 8 into a user's mouth, according to one embodiment.

Fig. 9B is a schematic diagram of a user performing a pumping exercise using the exercise device of fig. 8, according to one embodiment.

Fig. 9C is a schematic diagram of a user performing a tongue compression exercise using the exercise device of fig. 8, according to one embodiment.

Fig. 10A-10D depict side views of various pump bulb shapes according to some embodiments.

11A-11I depict top cross-sectional views of various pump bulb cross-sectional shapes according to certain embodiments.

Fig. 12A-12D depict side views of various nozzle shapes according to some embodiments.

FIGS. 13A-13F depict embodiments in accordance with certain implementations example side views of various distal opening configurations.

14A, 14C, 14E, 15A, 15B, and 15C depict cross-sectional side views of various flow restriction sections according to certain embodiments.

14B, 14D, and 14F depict cross-sectional top views of the flow restriction sections of FIGS. 14A, 14C, and 14E, respectively, according to certain embodiments.

Figures 16A-16H depict side cross-sectional views of various connection structures for connecting a bulb to an elongated tube, according to some embodiments.

Fig. 17A and 17B depict cross-sectional side views of additional flow restriction mechanisms according to some embodiments.

Fig. 18 is a perspective view of another exercise device according to another embodiment.

FIG. 19A depicts a side view of a suction nozzle according to an embodiment.

FIG. 19B depicts a top view of the suction nozzle of FIG. 19A, according to one embodiment.

FIG. 19C depicts another top view of the suction nozzle of FIG. 19A, according to an embodiment.

Fig. 20 is a side view of another exercise device according to another embodiment.

Fig. 21A depicts a top view of another exercise device according to another embodiment.

Fig. 21B depicts a side view of the exercise device of fig. 20A, according to one embodiment.

Fig. 21C depicts a perspective view of the exercise device of fig. 20A, according to one embodiment.

Fig. 22A depicts a side view of another exercise device according to another embodiment.

Fig. 22B depicts another side view of the exercise device of fig. 22A, according to one embodiment.

Fig. 23A depicts a side view of another exercise device according to another embodiment.

Fig. 23B depicts another side view of the exercise device of fig. 23A, according to one embodiment.

Fig. 24 depicts a side view of another exercise device according to another embodiment.

Detailed Description

The various apparatus and method embodiments disclosed herein address the burden of learning, implementing and improving upper airway exercise by facilitating and directing oropharyngeal exercises to strengthen muscles in the mouth and throat by providing a standardized set of exercises and treatment ranges that can be incorporated into a person's daily drinking/eating routines.

According to one embodiment, the device includes a liquid delivery mechanism that requires the user to perform repeated exercises in order to push liquid out of the mechanism so that the user can drink the liquid. The device may allow a user to deliver water with a specific motion, thereby enhancing various muscles in the oral cavity (including, for example, tongue, soft palate, and/or pharyngeal dilation muscles), while also providing a duration of repetition, hold, and/or resistance to enhance effectiveness.

The various embodiments disclosed or contemplated herein are for blending treatment with normal daily life, so the patient no longer needs to create a separate exercise routine, spend little time on treatment during her day, and/or she does not have to be psychologically focused on treatment. This makes the treatment almost non-burdened to the patient and creates a treatment where the patient does not have to think or even consciously know the treatment.

According to some embodiments, the device may be discrete so that patients can carry the device with them, can administer therapy whenever they want, and/or do not have to worry about using the device/administering therapy in public places. This changes how the exercise routine is implemented on the patient and gives the option of low intensity and high frequency/duration exercises that can be implemented throughout the day.

Various embodiments of the devices disclosed or contemplated herein may also promote proper hydration, which may have beneficial effects. The device according to various embodiments may be used intuitively and may guide appropriate exercise techniques.

Fig. 1A-1C depict one exemplary embodiment of an oropharyngeal exercise device 10, wherein the device 10 is a liquid container (such as a bottle or other type of container) 10 having an elongated tube (or "straw") 12 with a bulb (also referred to as "oral bulb," "pump nozzle," and "oral nozzle") 14 disposed at a distal end as shown. In this particular embodiment, the container 10 has a container body 16 and a removable cover 18 having an opening 20 defined therein such that the elongate tube 12 and bulb 14 can be disposed through the opening 20. Thus, the tube 12 extends into the interior of the body 16 such that the proximal end of the tube 12 is disposed at or near the bottom of the container body 16 as shown. In addition, the pump bulb 14 extends from the cover 18 so that a user can insert the bulb 14 into the user's mouth to perform a desired exercise in order to push water from the container body 16 through the tube 12 and bulb 14 into the user's mouth. Such a liquid containment device 10 having a pump bulb 14 may allow the treatment to be discrete, portable, and/or be part of daily life.

According to some embodiments, the removable cover 18 may have a removable protective cover 22 that may be removably disposed over the bulb 14 to protect the bulb 14 when the device 10 is not in use. In the particular embodiment depicted, the cover 22 is rotatably attached to the hood 18 at a joint such that the cover 22 is attached to the hood 18 and is rotatably movable between a covered position (not shown) and an open position (as shown in fig. 1A-1C). Alternatively, the removable cover 22 may be attached to the shroud 18 via any known mechanism.

In addition, the shroud 18 may also have a handle 26 attached thereto that a user may use to carry the device 10 or attach the shroud 18 to another object. In this embodiment, the handle 26 is a ring 26. Alternatively, the handle 26 may take any known form for grasping onto the device 10 or attaching the device 10 to another object.

The cover 18 may be removably coupled to the container body 16 via any known attachment mechanism, including, for example, threads, a snap-fit mechanism, and the like.

In certain alternative embodiments, the cover 18 need not be a removable cover 18 as described above. Rather, the structure to which the pump bulb 14 is attached may be a permanent cover or cap or top on the disposable container. Alternatively, the structure may be another structure on the container, such as a sidewall of the container. Thus, the bulb 14 may be coupled with an opening on any known structure of any known type of container.

In one embodiment, the pump bulb 14 of the device 10 is depicted in greater detail in fig. 2A through 3C. Alternatively, it should be understood that the pump bulb 14 incorporated into the device 10 may be any bulb embodiment disclosed or contemplated herein, including but not limited to the embodiments of fig. 6, 8, 10A-13F, 18, and 20.

The pump bulb 14 as shown in fig. 2A-3C may be used not only in the device 10 as described above and depicted in fig. 1A-1C, but in any other device embodiment disclosed or contemplated herein. As best shown in fig. 2A-2D and 3A and 3B, the bulb 14 has a body 40 with a distal extension (also referred to as a "suction nozzle") 42, a proximal extension 44, and a central body (also referred to as a "connector" or "attachment collar") 46 disposed between the distal extension 42 and the proximal extension 44. In this embodiment, the central body 46 is an attachment collar 46 having a slot (or channel) 48 defined within the collar 46 such that the slot 48 may be used to removably attach the bulb 14 to a container device (such as the device 10 described above) or any other device into which the bulb 14 is to be incorporated or to which the bulb 14 is to be attached. Alternatively, any known attachment feature or mechanism may be used or incorporated in place of the attachment collar 46. As best shown in fig. 3A and 3B, the main body 40 defines an internal cavity (or "lumen") 50 within the suction nozzle 42, the attachment collar 46, and the proximal extension 44 such that the lumen 50 extends along the length of the main body 40.

In one embodiment, the mouthpiece 42 has an oval shape as best shown in fig. 2A, 2E and 3C, such that the mouthpiece 42 fits well within the user's mouth. Thus, as best shown in FIG. 2A, the width W of the suction nozzle 42 is greater than its depth D. The width W of the suction nozzle 42 is depicted in fig. 2C and 3A, while the depth of the suction nozzle 42 is depicted in fig. 2D and 3B. In one embodiment, the width W is 9mm and the depth D is 6mm. Alternatively, the width W may vary from about 1mm to about 45mm, or in another alternative, the width W may vary from about 3mm to about 20 mm. According to yet another alternative, the width W may vary from about 10mm to about 17 mm. In a further alternative, the depth D may vary from about.2 mm to about 40mm, or in another alternative, the depth D may vary from about 1mm to about 15 mm. According to yet another alternative, the depth D may vary from about 6mm to about 13 mm. Further, the dimensions of both the width W and the depth D may also be any size between these ranges. In some embodiments, the exact width and depth dimensions of the mouthpiece can be adjusted to best fit the user's mouth. Alternatively, the mouthpiece 42 may have any known cross-sectional shape that facilitates positioning the mouthpiece 42 in the user's mouth.

As best shown in fig. 12A-12D, any nozzle in any bulb embodiment herein may have any number of configurations. For example, the mouthpiece 170 may have a cylindrical shape as shown in fig. 12A, with an opening 171 defined in the distal tip. Alternatively, the suction nozzle 172 may have a cylindrical shape with a rounded bulb at the distal tip, as shown in fig. 12B. In another alternative, as shown in FIG. 12C, the suction nozzle 174 has a cylindrical shape with a flat end. Additionally, FIG. 12D depicts a nozzle 176 having an inverted end.

In addition to the cross-sectional shape, the pump bulb 14 is also structured such that the length of the mouthpiece 42 also fits adequately within the mouth of the user. More specifically, the diameter of the central body 46 is greater than the diameter of the suction nozzle 42, so that the proximal end of the suction nozzle 42 is clearly defined by the projection of the body 46. Thus, the central body 46 acts as a barrier, thereby preventing the user from inserting the bulb 14 further into the user's mouth. In other words, the barrier of the central body 46 at the proximal end of the mouthpiece 42 defines the length of insertion of the mouthpiece 42 into the user's mouth. Alternatively, instead of a collar or protrusion, any of the bulb embodiments herein (including the bulb 14) may have a central body that is a notch or recess such that the central body allows the user to position her lips or teeth within the notch, thereby serving a similar purpose of establishing the length of the mouthpiece 42 during use. In a further alternative with respect to any of the embodiments herein, an outer diameter of the central body is substantially similar or identical to an outer diameter of at least one of the proximal extension and the suction nozzle such that there are no protrusions or recesses along a length of the bulb.

According to one embodiment, the suction nozzle 42 has a length of about 35mm from the tip 54 to the collar 46. Alternatively, the length may vary from about 7mm to about 65mm, or in another alternative, may vary from about 15mm to about 50 mm. According to yet another alternative, the length may vary from about 25mm to about 45 mm. Further, the length dimension can be any length between these ranges. In some embodiments, the length of the mouthpiece may be varied to best fit the user's mouth.

In certain embodiments, the width and length of the suction nozzle 42 are sized to provide sufficient surface area for a user to deform (such as, for example, compress) during use thereof, as will be described in more detail below. Further, according to various embodiments, the volume of the internal lumen 50 is sized to limit the amount of water that will be pushed into the user's mouth at one time, thereby increasing the number of actions required by the user to drink an amount of water on the mouthpiece 42 (and thereby increasing the user's exercise).

The suction nozzle 42, as well as all other suction nozzle embodiments disclosed or contemplated herein, together have at least one opening 52 defined therein that provides fluid communication between the exterior of the suction nozzle 42 and the internal lumen 50 defined therein. According to one embodiment, as best shown in fig. 2A and 2E, the at least one opening 52 is a single slot 52 defined in a tip 54 of the suction nozzle 42. In certain particular embodiments, the slit 52 may have a stress relief opening 53 defined at each end of the slit 52, such that the relief opening 53 helps reduce stress at each end of the slit 52 and thereby prevents or reduces the amount of tearing of the slit 52 at each end during use. Alternatively, any known mechanism or structure for reducing stress on the opening 52 may be incorporated into the opening 52. According to the illustrated embodiment, the slit 52 is disposed on the tip 54 such that the length of the slit 52 is horizontal relative to the width W of the mouth 42. Because the user may insert the mouthpiece 42 into her mouth such that its width W is horizontal relative to the user's lips, any force applied by the user's lips is applied in a direction transverse to the length of the slit 52. Thus, the force does not cause the slit 52 to open and allow liquid to flow easily through the slit. In contrast, if the length of the slit 52 is parallel to the force applied by the user's lips or teeth, the user can bite down or compress the suction nozzle 42 and cause the slit 52 to open and allow the liquid to pass through without having to properly perform the targeted exercise. The benefits of the slits 52 in the operation of the suction nozzle 42 will be discussed in more detail below.

Alternatively, the at least one opening 52 in various embodiments herein may be one or more openings of any number of known shapes or configurations. That is, any number of other opening configurations, shapes, or configurations may have the same characteristics and benefits as the slit 52 described above. For example, a plurality of small circular openings may also provide substantial restriction of flow until a predetermined amount of negative pressure is applied by the user, as will be described in detail below. In addition, other opening configurations may produce the same effect.

According to some embodiments, the proximal extension 44 is substantially circular and has a circular opening 56, best shown in fig. 2B and 2F, in fluid communication with the internal lumen 50. The circular shape of the extension 44 and the circular shape of the opening 56 facilitate attachment of the proximal extension 44 to an elongated tube (such as the tube 12 discussed above) or any tube embodiment disclosed or contemplated herein having a generally circular cross-section.

As mentioned above, certain embodiments of the collar 46 have a channel 48 defined around the periphery of the collar 46 such that the channel 48 may be used as an attachment assembly or mechanism. More specifically, in those embodiments in which the pump bulb 14 is incorporated into a container (such as the container 10 discussed in detail above), the opening in the container through which the bulb 14 is positioned (such as the opening 20 above) may have a lip (not shown) around the inner surface of the opening. Thus, when the bulb 14 is pushed into position within an opening in the container (such as opening 20 discussed above) to attach the bulb 14 thereto, the channel 48 is positioned within the opening such that a lip (not shown) is disposed within the channel 48, thereby providing a sealed coupling of the collar 46 with the cover or other component in which the opening (such as opening 20) is defined. Alternatively, in those embodiments in which any of the bulb embodiments are not used with a container, the bulb need not have a channel.

As best shown in fig. 3A and 3B, the inner lumen 50 may have a lip 58 defined within the collar 46 that serves as a straw advancement barrier. That is, the lip 58 has a narrower diameter along the length of the proximal extension 44 than the inner lumen 50. Further, the lip 58 is configured to have a narrower diameter than an elongated tube or straw (such as tube 12) inserted into the interior lumen 50 of the proximal extension 44, such that the straw can only be inserted into the lip 58. Thus, the bulb 14 is configured to prevent the insertion of a straw into the suction nozzle 42, thereby eliminating any risk of the straw negatively affecting the structural characteristics of the suction nozzle 42.

In one embodiment, the pump bulb 14 (as well as any other pump bulbs disclosed or contemplated herein) is a single, unitary component made of silicone that is safe for the user. Alternatively, the bulb 14 (or any other bulb as disclosed or contemplated herein) may be made of any other known material that is pliable and may be compressed along with the tongue. This may include a sponge-like material, a woven material, a mesh-like material, a fabric-like material, a rubber material, a plastic material, and/or any other known material that may be placed safely into a person's mouth and meet the desired mechanical properties. In certain embodiments, the material may have a smooth and/or soft surface texture so that the user may comfortably use the material and/or the device may reduce wear on the tongue and mouth. The material can be easily cleaned and/or does not harm the dishwasher.

According to one embodiment, the material of the bulb 14 has a hardness of 30A durometer. Alternatively, the durometer of the bulb 14 material may be in the range of about 0A durometer to about 100A durometer, or in another alternative, may be in the range of about 15A to about 75A. According to yet another alternative, the hardness may vary from about 25A to about 45A. Further, the hardness can be any amount of hardness between these ranges. As discussed in more detail below, the durometer of the bulb 14 material may be modified to vary the resistance of the bulb 14 to the user's effort to urge liquid from the internal lumen 50 into the user's mouth, thereby adjusting the resistance to a desired level in favor of the user.

According to some embodiments, the walls of the suction nozzle 42 have a thickness of about 1.5mm along the length of the suction nozzle 42 (the sides of the suction nozzle 42) and a thickness of about 1mm at the tip 54. Alternatively, the thickness of the sidewalls and tip of the mouthpiece 42 may vary from about.1 mm to about 10mm, or in another alternative, from about.3 mm to about 5 mm. According to yet another alternative, the thickness may vary from about.5 mm to about 2 mm. In these embodiments, the thickness of the walls of the tip 54 is less than the thickness of the side walls of the suction nozzle 42 in order to ensure that the resistance of the suction nozzle 42 feels uniform at the tip 54 and along the side walls of the suction nozzle 42.

Various characteristics of the suction nozzle 42, including the wall thickness, stiffness, shape, and size of the opening 52 (such as the length of the slit 52), are factors that affect the resistance of the suction nozzle 42 and the flow of liquid through the opening 52 as the suction nozzle 42 is manipulated by a user during use, as will be discussed in further detail below. Accordingly, any one or more of these factors may be varied to adjust the resistance and/or fluid flow of the mouthpiece 42 to the level desired by a particular user.

The treatment provided by any of the various devices disclosed or contemplated herein may enhance the muscles of the tongue, particularly the genioglossus muscle. As best shown in fig. 4A-4C, according to certain embodiments, 4 primary exercise motions may be performed using the device embodiments herein, including a tongue suction exercise 70 (as shown in fig. 4A), a tongue compression exercise 72 (as shown in fig. 4B), a tongue push exercise 74 (as shown in fig. 4C), and a swallowing exercise (not shown), which involve repeated swallowing as an exercise. As will be discussed in further detail herein, the various device embodiments herein may be used by a user to perform at least one or any combination of these exercises. Moreover, as explained further herein, certain device embodiments enhance the ability of a user to perform one or more of these exercises.

The tongue suction exercise as shown in fig. 4A involves bolus formation in an attempt to mimic normal swallowing. That is, the tongue 76 creates a bolus by extending toward the bottom of the mouth. This creates a negative pressure and the edge of the tongue 76 flexes upward, creating a bowl or trough. This is for use of the genioglossus muscle, and without being limited by theory, it may also be for the hyoglossus, palatoglossus and transverse muscles of the tongue 76. Other muscles it may target are the stem tongue of the tongue 76 and the vertical muscles.

The tongue compression exercise shown in fig. 4B is a motion that mimics the upward pressure of the tongue 76 during swallowing to push a bolus of food or liquid into the pharyngeal cavity. The tip of the tongue 76 presses up against the hard palate behind the anterior incisors and the back of the tongue 76 presses up in a wave-like motion pushing the bolus towards the back of the throat. Without being limited by theory, it appears that the superior longitudinal muscle is activated along with the genioglossus muscle, the hyoglossus muscle, and the palatoglossus muscle.

The tongue pushing exercise shown in fig. 4C is a movement of the tongue 76 stuck outside the mouth in a linear motion. This exercise activates the genioglossus muscle, and if the tongue 76 is pointed, it also activates the transverse lingual muscle. When extended, the motion may also have a leftward, rightward, upward, or downward motion to increase the range of motion and strengthen additional muscles and/or target specific muscles.

In one embodiment, the exercises that may be performed by a user using any of the device embodiments disclosed herein may combine tongue suction and tongue compression exercises. These exercises are natural movements used in swallowing actions, they balance each other and activate different muscle groups, and they activate most or all of the muscles of the tongue. In addition to strengthening the muscles of the tongue and throat, this treatment may also improve swallowing ability. This treatment method may also promote this location by exercising the tongue in a manner that places the tongue near the correct resting position of the tongue, and strengthen the muscles that may make the tongue more naturally enter this location. Such treatment may be beneficial to snorers, sleep apnea patients, dysphagic patients, elderly people with dysphagia, people who want to tighten muscles to look more beautiful, people who want to correct their resting position of the tongue, and anyone who wants to improve the strength and endurance of their tongue.

Alternatively, any combination of the three therapeutic exercises described above may be performed using any of the device embodiments disclosed or contemplated herein.

The method of performing the various exercises herein using any of the various apparatus embodiments has many benefits to the user. For example, rather than expecting a user to schedule and attempt to perform exercise using any of the known exercise devices available, the various device embodiments disclosed or contemplated herein link treatment with the bio-driving effects of drinking. Furthermore, the treatment is portable and can be performed anywhere as appropriate and convenient, it is easy to track (e.g., by counting the number of liquid bottles consumed), it promotes hydration, and it provides desirable physical improvements, including reducing snoring, reducing fatigue, improving nasal breathing, improving tongue placement, adjusting jaw lines, reducing sleep problems, and improving energy. Other benefits are discussed elsewhere herein.

According to certain alternative embodiments, various exercises herein may produce additional therapeutic benefits. For example, one such therapeutic benefit may be nasal breathing during treatment. More specifically, nasal breathing activates the muscles of the palate and is promoted in the treatment of muscle function. In addition, according to another example, swallowing exercise (in conjunction with increasing the number of swallows) activates the muscles of the soft palate.

Among the benefits of the various device embodiments herein and methods of use thereof, the use of any of the devices herein for daily hydration results in the user no longer being forced to think about treatment or determine when to perform exercise. Instead, exercise is part of normal daily life with drinking. As will be described in detail elsewhere herein, many of the various device embodiments herein can be used with a water bottle, straw, cup, hood, or any other known drinking device that can be combined with the various embodiments herein for incorporation into the daily life of a user drinking water. In further alternatives, liquids, semi-liquids, or soft solids other than water may be used in the various devices herein.

Returning now to the pump bulb 14 of fig. 2A-3C, in view of the above-described exercises, according to some embodiments, the combination of the suction nozzle 42 structural characteristics and the slit 52 in its tip 54 are configured to enhance the benefits of these exercises. More specifically, the wall thickness of the tip 54 (as discussed above) as well as the hardness and length of the slit 52 determine the amount of force required to open the slit 52 during use, thereby affecting the effort that the user must make to push liquid therethrough (assuming, of course, that the mouthpiece 42 is properly positioned in the user's mouth). For example, during a tongue suction exercise, the slits 52 establish a threshold value for the force that a user must apply via tongue suction in order to pass liquid through the slits 52. This threshold ensures that the user must use sufficient force to exercise via tongue suction to provide the user with the desired exercise benefit. Furthermore, since the desired additional force/pressure is applied to the suction nozzle 42 via the tongue suction action and the tongue suction exercise is performed properly, the combination of the flexibility of the slit 52 and the tip 54 material allows the slit 52 to expand into larger pores, thereby allowing a greater degree of liquid flow. This expansion and increased liquid flow of the slits 52 allows the user to receive enough liquid to replenish the user with moisture/meet the user's thirst requirements. The resulting flow change (if graphed) will show a sigmoidal curve. Thus, the configuration of the tip 54 and the slit 52 provides two configurations: (1) An initial reduced flow configuration in which the slits 52 restrict flow and require additional force to be applied by the user, thereby encouraging the user to optimize his exercise (thereby enhancing his benefit), and (2) a subsequent enhanced flow configuration in which the slits 52 open as a result of the additional force applied by the user, thereby allowing sufficient flow to meet the user's thirst requirements. That is, this structure creates an "uhaha" effect for the user, as she knows she is performing the exercise correctly and applying enough force, as she starts to flow more liquid into her mouth with less relative effort.

As discussed above, various other opening configurations may produce the same benefits as the slit 52 described above. For example, a plurality of small circular openings may also provide a substantial restriction to flow until a predetermined amount of negative pressure is applied by the user. In addition, other opening configurations may produce the same effect. Conversely, if the opening is a larger and/or less restrictive opening, rather than a slit 52 or other restrictive opening, the added effect of increased liquid flow after the minimum threshold is cleared will not occur, and the user will not receive an indication of proper action as described above. Conversely, the user may sipper a bite at a lower or higher pressure, with the flow varying linearly with increasing pressure.

In use, as shown in fig. 5A and 5B, a pump bulb (such as bulb 14 described above) may be used to perform a tongue suction exercise 80, for example as shown in fig. 5A, a tongue compression exercise 82, as shown in fig. 5B, or both. In addition, additional exercises, such as tongue pushing exercises, may also be performed. In the particular embodiment depicted in fig. 5A and 5B, exercise is performed using the pump bulb 14 incorporated into the liquid container 10 described in detail above. Alternatively, any of the apparatus embodiments disclosed or contemplated herein may be used to perform these exercises.

As shown in FIG. 5A, a tongue suction exercise as described above is performed using a container apparatus 10 having a bulb 14. During exercise, the tongue 86 extends toward the bottom of the mouth, creating a space between the tongue 86 and the hard palate 84, and thereby creating a negative pressure in the mouth of the user, causing suction to be applied to the bulb 14.

Further, as shown in fig. 5B, the tongue compression exercise as described above is performed using the device 10 and bulb 14. During exercise, the tongue 86 presses up against the hard palate 84 to mimic the swallowing action of pushing food or liquid into the pharyngeal cavity. More specifically, the tip of the tongue 86 is pushed into contact with the hard palate 84 behind the front incisors and the back of the tongue 86 is pushed upward in a wave-like motion so that if food/liquid is present, the tongue 86 will push the food/liquid toward the back of the throat.

Fig. 6-7C illustrate another exemplary embodiment of an exercise device 100. In this embodiment, the device 100 is an elongated tubular body (or "straw") 102 having a pump bulb (also referred to as a "perforated bulb" or "perforated mouthpiece") 104 disposed at its distal end. According to one embodiment, a bulb 104 is attached to the distal end of the tube 102. Alternatively, the bulb 104 is integral with the tube 102 such that the bulb 104 and the tube 102 comprise a single assembly. The bulb 104 has a suction nozzle section 104A distal to the tube 102 and a proximal section 104B where the bulb 104 overlaps or couples with the tube 102. As with the bulb 14 described above, the proximal section 104B is less flexible and does not have the same structural features as the suction nozzle 104A. The bulb 104 has a cylindrical shape with a rounded tip 106. Further, the bulb 104 in this exemplary embodiment has a lumen 108 defined therein, and has a plurality of openings (or "perforations") 110 defined in the wall of the bulb 104 that provide a fluid pathway between the lumen 108 and the exterior of the bulb 104. Alternatively, the bulb 104 may have one opening, two openings, or any number of openings. In the particular embodiment shown, the opening 110 is a circular hole or perforation 110. Alternatively, the opening 110 may have any known shape (including, for example, a slit shape).

In general, any of the various mouthpiece embodiments disclosed or contemplated herein may have any opening configuration, shape, or number as described above. Thus, the openings may be a plurality of openings, three openings, two openings, a single opening, or any number of openings. For example, in FIG. 13A, the suction nozzle 170 has a plurality of circular openings 172. Alternatively, as shown in FIG. 13B, the suction nozzle 170 has a single opening 174. In another embodiment, as shown in FIG. 13C, the suction nozzle 170 has a plurality of X-shaped openings 176. According to another alternative shown in FIG. 13D, the suction nozzle 170 has a plurality of larger openings 178 (larger than the openings 172 of FIG. 13A). Further, according to another embodiment, as shown in fig. 13E, the suction nozzle 170 has a plurality of slits 180. Yet another embodiment, shown in fig. 13F, is a mouthpiece 170 having a single opening 182 defined in the distal tip of the mouthpiece 170. Alternatively, the openings may have any other geometry that allows for the passage of fluid. The opening diameter, shape and/or configuration may be designed to be closed during tongue suction exercises and open during tongue compression exercises. Alternatively, the openings may be opened throughout the tongue compression exercise and tongue suction exercise, or in another alternative, may be opened and closed throughout the procedure. According to various embodiments, the openings may be in different locations on the mouthpiece. Various configurations may also help reduce water spray to the back of the user's throat and thereby cause discomfort.

Except as described herein, the bulb 104 operates in the same manner as the bulb 14 embodiment discussed in detail above, or any other bulb embodiment herein, such that the device 100 may be used to perform any one or more of the three exercises discussed above. Moreover, any of the additional/optional features described above with respect to other embodiments may be incorporated into the apparatus 100, where feasible. Unlike the device 10 discussed above, the present exercise device 100 is simply a tube 102 and bulb 104, which means that the device 100 can be inserted into and used with any fluid container.

In use, as best shown in fig. 7A-7C, a user may place the bulb 104 in the user's mouth (as best shown in fig. 7A) and perform a tongue suction exercise (as shown in fig. 7B) or a tongue compression exercise (as shown in fig. 7C). In addition, the user may also perform tongue pushing exercises as described elsewhere. The bulb 104 may be used to perform various exercises in substantially the same manner as described above, and therefore the performance of these exercises will not be described in greater detail herein.

In fig. 8-9C, another embodiment of an exercise device 120 is depicted in which the device 120 is an elongated tube (or suction tube) 122, and a pump bulb 124 is disposed at the distal end of the tube 122, wherein the bulb has an opening 126 defined in its distal end 128. According to one embodiment, a bulb 124 is attached to the distal end of the tube 122. Alternatively, the bulb 124 is integral with the tube 122 such that the bulb 124 and the tube 122 comprise a single assembly. The bulb 124 has a suction nozzle section 124A distal to the tube 122 and a proximal section 124B where the bulb 124 overlaps or couples with the tube 122. As with the

bulbs

14, 104 described above, the proximal section 124B is less flexible and does not have the same structural features as the suction nozzle 124A. The bulb 124 has a generally cylindrical shape with a tapered section 130, a distal cylindrical section 132, and a proximal cylindrical section 134 having a diameter that is smaller than the diameter of the distal cylindrical section 132. Further, the bulb 124 has a lumen 134 defined therein that is in fluid communication with the distal opening 126 such that the opening 126 provides a fluid pathway between the lumen 134 and the exterior of the bulb 124. Except as described herein, the bulb 124 operates in the same manner as the

bulb

14, 104 embodiment discussed in detail above, or any other bulb embodiment herein, such that the device 120 may be used to perform any one or more of the three exercises discussed above. Moreover, any of the additional/optional features described above with respect to other embodiments may be incorporated into the apparatus 120, where feasible. Similar to the device 100 described above, the present exercise device 120 is simply a tube 122 and bulb 124, meaning that the device 120 can be inserted into and used with any fluid container.

In use, as best shown in fig. 9A-9C, a user may place the bulb 124 in the user's mouth (as best shown in fig. 9A) and perform a tongue suction exercise (as shown in fig. 9B) or a tongue compression exercise (as shown in fig. 9C). In addition, the user may also perform tongue pushing exercises as described elsewhere. The bulb 124 may be used to perform various exercises in substantially the same manner as described above, and therefore the performance of such exercises will not be described in greater detail herein.

As mentioned above, any of the various pump bulb features and/or components described herein with respect to any of the various device embodiments may be incorporated into any of the other bulb implementations. Further, any of the pump bulb embodiments herein may be incorporated into or used with any of the container embodiments disclosed or contemplated herein.

The various pump bulb embodiments herein can have any shape that readily fits into the oral cavity. Some non-limiting exemplary shapes of bulb embodiments are depicted in fig. 10A through 10D. More specifically, fig. 10A depicts a cylindrical bulb shape 140, while fig. 10B depicts a generally spherical bulb shape 142. Further, fig. 10C depicts a trapezoidal bulb shape 144, while fig. 10D shows a bulb 146 shaped with two spherical segments. Alternatively, any bulb may have any known shape, and in further alternatives may have two or more segments of any known shape.

Various alternative embodiments may also have any known cross-sectional shape that may be incorporated into any pump bulb embodiment. For example, various bulb embodiments may have a circular shape 150 (as shown in fig. 11A), a rectangular shape 152 (as shown in fig. 11B), a trapezoidal shape 154 (as shown in fig. 11C), an oval shape 156 (as shown in fig. 11D), a triangular shape 158 (as shown in fig. 11E), a triangular shape 160 with rounded corners (as shown in fig. 11F), a pentagonal shape 162 (as shown in fig. 11G), a different pentagonal shape 164 (as shown in fig. 11H), or a hexagonal shape 166 (as shown in fig. 111). Further, in any of the embodiments herein, the distal end may be rounded, flattened, inverted, open, or have any other known configuration. Further, in various alternative embodiments, the pump bulb may narrow in some regions and/or widen in other regions. Further, in certain exemplary embodiments, the pump bulb may be designed to look like a nozzle so that it looks discrete.

Also as discussed above, in the various bulb embodiments disclosed or contemplated herein, there may be a variety of predetermined variations in the hardness, thickness, volume, and/or size of the bulb to allow for different oral sizes for different levels of treatment, repetition of treatment, and/or different users. By having different material thicknesses, different shapes, having a filler material, being honeycomb shaped, hollow, having a ridged structure, and/or having multiple bulb structures, any of the various bulb embodiments may distribute the force required by the user to compress the bulb in different ways to provide targeted therapy.

Further, any of the embodiments may also have features, mechanisms, or be structurally configured for guiding proper movement of the oral cavity during the tongue compression exercise by compressing the bulb in a predetermined manner based on structural features of the bulb. According to some embodiments, instructions may be provided to the user to ensure proper performance of the exercise. Alternatively, no instructions are required.

In other embodiments with respect to any of the bulb embodiments disclosed or contemplated herein, the bulb characteristics may be adjusted to enhance the benefits of the tongue compression exercise. That is, in some embodiments, the resilient nature of the bulb material may cause the bulb to reform to its original shape after being compressed. When the bulb returns to its original shape, the suction nozzle opening is sealed such that a negative pressure is created within the bulb, thereby filling the internal lumen of the bulb with liquid via the opening in the proximal extension. Once the bulb contains the desired amount of liquid, the bulb, when compressed by the user, can overcome the seal of the mouthpiece opening, thereby causing the mouthpiece material to deform such that the internal pressure increases to a level that overcomes the seal of the bulb opening.

Alternatively, other bulb embodiments are configured to fill the liquid by using gravity, such that the bulb (and in some embodiments, the container attached thereto) is tilted, thereby causing the bulb to fill with the liquid, such that the user may then use the mouthpiece to perform a tongue depressing exercise to drink water. In another alternative, any of the system embodiments herein may have a container (to which the bulb is attached) configured to create a positive pressure. In various embodiments, this positive pressure may be created by, for example, reducing the volume of the container in some manner (such as by compressing the volume of the container) and/or by adding air to the container.

In certain embodiments, as best shown in fig. 14A and 14B, the inner lumen of any of the bulb embodiments herein (such as the exemplary bulb 200 shown) may have at least one section or length therein defining a narrow diameter 204 to limit airflow therethrough. The narrow diameter section (or "flow restriction section" or "neck") 204 results in a small opening or lumen 206 being formed anywhere along the length of the lumen 202 within the bulb 200. That is, the narrow section 204 may be defined within any one or more of the proximal extension, collar, and/or mouthpiece of any of the bulb embodiments herein. In one embodiment, the small opening 206 may have a diameter of about.9 mm. Alternatively, the small opening 206 may have a diameter of about.1 mm to about 2 mm. In further embodiments, as shown in fig. 14C and 14D, the narrow section 204 may be two or more small openings 210 that have the same effect as a single small opening 206.

In another alternative, instead of a narrow section, any bulb embodiment herein may have a throttle valve-such as a one-way valve or a check valve-that requires force to open it in each flow direction. As with the narrow section, any such valve can be disposed anywhere along the length of the bulb lumen. For example, in one particular embodiment, as shown in fig. 14E and 14F, the bulb 200 may have a one-way valve 220 disposed within the lumen 202. In an additional alternative, the one-way valve may be any of the valve configurations shown in fig. 15A-15C, including a ball valve 222 in fig. 15A, a flapper valve 224 in fig. 15B, and a diaphragm check valve 226 in fig. 15C. Further, any known valve configuration may be used in various embodiments herein.

According to yet another alternative, the restriction may be an adjustable valve. For example, in one embodiment shown in fig. 17A, bulb 260 has a control valve 262 with a handle 264 that can be rotated or otherwise manipulated to adjust the position of valve body 266 within lumen 268, thereby adjusting the size of the opening within lumen 268. Alternatively, according to another embodiment shown in FIG. 17B, bulb 260 has a screw valve 270 having a handle 272 that can be rotated or otherwise manipulated to adjust the position of a valve body 274, thereby adjusting the size of the opening within lumen 268.

Whether configured as a narrow section or a valve, the lumen restrictor may increase the pressure that a user needs to apply during a tongue suction exercise in order to increase the flow of liquid therethrough. In addition, the restraint may reduce backflow of fluid during tongue compression exercises. Alternatively, the restriction may be a restrictive aperture defined in the shroud in any of the container embodiments herein. That is, instead of a restriction within the bulb, an additional opening is defined in the container hood such that air entering the container is restricted by the opening, thereby causing an increase in negative pressure as liquid is pushed out of the container (through the bulb) at a rate faster than the rate at which air is allowed to enter through the opening.

As discussed above, any of the bulbs herein can be integral with or attached to the tube and/or straw. Furthermore, any bulb herein is also attached to the liquid container or the cover of the container. In various embodiments, the bulb may be removable from the elongated tube to allow for easier cleaning and/or replacement with a different bulb. The bulb may be attached to the elongated tube using various attachment methods and mechanisms. For example, in one embodiment, as shown in fig. 16A, the bulb 230 is attached to the elongated tube 232 via a compression fit 234. Alternatively, as shown in fig. 16B, the bulb 230 is attached to the tube 232 via an internal compression fit 236. In another alternative embodiment, as shown in fig. 16C, the bulb 230 is attached to the tube 232 via an internally threaded connection 238. Further, as shown in fig. 16D, the connection may be an externally threaded connection 240. According to yet another alternative, as shown in fig. 16E, the connector may be an external groove connector 242, or in another alternative, the connector may be an internal groove connector 244, as shown in fig. 16F. Another implementation according to another embodiment is depicted in fig. 16G, which shows a latch connection 246 connected, while fig. 16H depicts another latch connection 248. Alternatively, any known attachment method or mechanism may be used. In addition, the various bulbs disclosed or contemplated herein may have lugs, plugs, markings, grooves, or some other known mechanism of controlling the distance the bulb is positioned on the tube. In another alternative, an O-ring may be used to help form a seal between the tube and the pump bulb.

Any pump bulb according to any of the various embodiments herein may be designed to be used throughout the day in a low-intensity, high-frequency manner, based on various bulb parameters as discussed above (including wall thickness, material hardness, shape, opening size in a narrow section, nozzle opening size/configuration, etc.). That is, the amount of force required to compress the bulb and draw liquid may be of a low intensity value to allow a normal amount of liquid (such as, for example, water) to be consumed throughout the day, including, for example, but not limited to, 16.9oz, 20oz, 24oz, 1L, 1.5L.

Alternatively, a pump bulb according to any of the embodiments disclosed or contemplated herein may be designed for high-intensity, low-frequency use. That is, the user may drink a smaller portion of water throughout the day to achieve a sufficient therapeutic level and then use an alternative method to drink the water. The user may adjust or change the exercise intensity at multiple levels. Such adjustments may include varying different pump bulbs having different compressive forces by varying wall thickness, shape, material hardness, opening size, or any other parameter discussed herein. According to certain embodiments, each bulb may be customized for the user and/or there may be bulbs with predetermined parameters for off-the-shelf use.

In certain embodiments, any of the device embodiments herein can be configured to provide the option of drinking normally if the user no longer wishes to exercise. For example, in one embodiment, the device allows the bulb to be removable. Further, in certain embodiments, any of the devices herein may provide a location for placement or attachment of the removed bulb to a bottle or cover or in a separate suitcase. Alternatively, the mouthpiece and/or bulb may be able to telescope into and out of the space defined within the bottle or shroud. In another alternative, the device may have a separate opening (separate from the bulb) on the cover or elsewhere that is open or can be opened for drinking without using the bulb. According to another embodiment, the mouthpiece or bulb may be rotated into the hood. In addition, the pump bulb may be turned inward and into the cover and/or the elongated tube.

In another embodiment, instead of controlling the resistance level via a bulb, the elongated tube is configured to create a desired resistance level for the user exercise. For example, as shown in fig. 18, the device 300 has a bulb 302 that is removably attached to an elongated tube (or "straw") 304 in a manner similar to other embodiments described elsewhere herein. In this particular embodiment, the medium within the device 300 may be air, rather than a liquid. Moreover, any of the other device embodiments disclosed or contemplated herein may be used with any form of fluid (liquid or gas). Alternatively, the bulb 302 may be integral with the suction tube 304 such that the bulb 302 and the suction tube 304 are one component. The suction pipe 304 is provided with two internal diameters: a first reduced inner diameter 306 and a second larger inner diameter 308. Thus, the length of the suction tube 304 having the reduced inner diameter 306 is the restricted air passage 306, which provides resistance to a user attempting to push air (or alternatively liquid) into their mouth during use. The bulb 302 may be configured in a manner similar to any other bulb embodiment or features thereof described in accordance with any embodiment disclosed or contemplated herein. In another embodiment using a gas, such as air, the bulb 302 may not have an opening defined therein.

Alternatively, the resistance created in the elongate tube may be in the form of a counter force, such as a balloon, valve, diaphragm, wheel, or any other known mechanism or feature for providing a desired level of resistance. For example, the opposing force may be an air bag (not shown) that inflates to create a resistance force. Alternatively, the resistance may be created by a combination of a bulb configuration and an elongated tube configuration.

In another embodiment, best shown in fig. 19A-19C, a bulb 320 is provided that can provide a fluid pathway via compression. More specifically, the bulb 320 has a suction nozzle 322 having an opening 324 defined within the bulb 320 that is openable by applying a compressive force to the suction nozzle 322. In the particular exemplary embodiment depicted, the distal end of the suction nozzle 322 has a large opening 326 defined therein, with the plurality of openings 324 being disposed within the large opening 326 such that the openings 324 are disposed a distance proximal of the distal end. More specifically, line a in fig. 19A depicts a cross-sectional aspect of the suction nozzle 322 captured in fig. 19B and 19C. Alternatively, the opening 324 may be provided at a distal end of the mouthpiece 322. The opening 324 is configured to open or increase in diameter upon application of a force. Thus, as represented by arrow B reflecting the applied force, the mouthpiece 322 may be compressed by the user (such as by the tip of the tongue and/or the back of the tongue) to open or widen the opening 324 to allow liquid to flow therethrough. In certain embodiments, portions or sections along the length of the suction nozzle 322 may be compressed to open a fluid path therein. One portion may be designed to be compressed with teeth, which may allow for proper positioning of the nozzle and/or prevent the use of the mandible in the tongue compression portion. According to some embodiments, the bulb 320 may have a raised portion and/or a tooth guard ("protrusion") 328 (as shown in fig. 19A) on the mouthpiece 328 to guide proper placement in the mouth. Once the mouthpiece 322 has been compressed as desired, gravity or other mechanism or method can allow the liquid to flow into the user's mouth.

According to another embodiment, a system 340 may be provided that combines a bulb 342 with a container hood 344 having a valve 346 for tongue-pushing exercises. The shield 344 is removably attached to the container 358. Alternatively, the shroud 344 may have any configuration and may be coupled to any type of container. The bulb 342 may be any bulb embodiment disclosed or contemplated herein, and may also have any of the additional or alternative features described herein. The valve 346 has a button 348, a valve body 350, a stem 352 coupling the button 348 to the valve body 350, and an extension spring 354 coupled to the button 348 such that the spring 354 urges the button 348 and the valve body 350 to their closed positions. The valve body 350 is disposed on the underside of the housing 344 in communication with an opening 356 defined in the housing 344. When the valve 346 is in the closed position, the valve body 350 is disposed against the underside of the housing 344 such that the valve body 350 seals the closed opening 356. Conversely, when the button 348 is pushed toward the shield 344 such that the valve 346 is pushed to the open position, the valve body 350 is pushed away from the underside of the shield 344 such that the opening 356 is in fluid communication with the interior of the container 358, thereby allowing fluid to flow through the opening 356. When the force is removed from the button 348 (i.e., the user stops applying the force via their tongue), the extension spring 354 pushes the button 348 back to its rest position (closed position). In this particular embodiment, the valve button 348 is disposed within a recess 360 defined in the shroud 344 such that the button 348 may be urged toward the shroud 344 within the recess 360. In use, according to one embodiment, a user may use a tongue-pushing exercise to press the button 348 "down" (toward the hood 344) so that liquid may flow through the opening 356. In addition, the user may also use the bulb 342 to perform other exercises as described elsewhere herein. Alternatively, other known mechanisms (such as a winding mechanism or any other known mechanism or assembly) may be used in place of the depicted exemplary valve 346. Regardless of the particular mechanism/assembly, the user's tongue will have to repeatedly press a button (using tongue pushing exercises) to open a valve to drink liquid.

Another embodiment of a mask 370 having a tongue push valve 372 is depicted in fig. 21A-21C. In this exemplary embodiment, the valve 372 is positioned such that the button 374 is ' hidden ' or separately positioned on the mask 370 such that the user's tongue pushing exercise cannot be seen by individuals in close proximity to the user during the exercise. In other words, the button 374 is positioned or the cover 370 is configured so that others cannot see what the user does with her tongue. In this particular embodiment, the shroud 370 has a lip (or "ridge") 376 extending outwardly from the periphery of the shroud 370 around at least a portion of the periphery to block visual access to the top surface 367 of the shroud 370 during use. Although a complete valve 372 having a valve body and other components is not shown, it should be understood that valve 372 has the same or substantially similar components as valve 346 described above, except as described herein. Alternatively, valve 372 may be any known valve having any known mechanism for operation.

In a further alternative tongue push valve embodiment as best shown in fig. 22A through 24, the valve may have a mechanism or feature for varying the force required for tongue push or pushing the button with the tongue a desired distance. For example, as best shown in fig. 22A-22B according to one exemplary embodiment, the cover 390 may have an adjustable lip 392 that may extend between a retracted position as shown in fig. 22A and an extended position as shown in fig. 22B or anywhere therebetween. This particular mechanism may be any known mechanism that causes the lip 392 to telescope or rotate between a retracted position and an extended position. Thus, the adjustable positioning of the lip 392 adjusts the distance from the cover lip 392 to the button 394, which is disposed on or near the top surface 396 of the cover 390. This adjustable feature of lip 392 allows adjustment of the distance that a user must extend his tongue in order to successfully depress button 394.

According to another alternative embodiment, a tongue-pushed valve embodiment as shown in fig. 23A and 23B has an adjustable force component. More specifically, a cover 400 is provided having a valve 402 with an adjustable extension spring 404 so that the amount of force required to push the valve 402 open can be adjusted. As shown, the extension spring 404 may be adjustable between a high tension configuration as shown in fig. 23A and a low tension configuration as shown in fig. 23B and anywhere therebetween. Thus, the user may adjust the spring 404, and thus the amount of force required to push the button 406 a set distance.

Yet another system embodiment for tongue pushing exercises is depicted in fig. 24, which shows a container 410 having a valve 412 with a button 414, a valve body 416, and an elongated rod 418 coupling the button 414 to the valve body 416. In this embodiment, valve body 416 is disposed proximate an outer surface of bottom wall 420 of inner container 422 (such that stem 418 extends through the interior of inner container 422, as shown) such that valve body 416 is in adjustable communication with opening 424 in bottom wall 420. In use, when the button 414 is pushed in by the tongue of a user, the valve body 416 is pushed away from the bottom wall 420, thereby allowing liquid from the outer container 426 to enter the inner container 422 through the opening 424. When the button 414 is released, the valve body 416 returns to its position in contact with the bottom wall 420, thereby closing the opening 424. The user may then drink the liquid in the inner container 422 and repeat the process as desired.

As discussed elsewhere in this application, the various components and/or features of the various embodiments disclosed or contemplated herein can be combined with any other embodiment and/or with any other component and/or feature.

Although various embodiments have been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

Claims

1. An oropharyngeal exercise device, the device comprising:

(a) A bulb body, the bulb body comprising:

(i) A mouthpiece sized and shaped to be insertable into a mouth of a user;

(ii) A proximal extension; and

(iii) A central body disposed between the suction nozzle and the proximal extension;

(b) A lumen defined within the bulb body such that the lumen is defined within the suction nozzle, the proximal extension, and the central body;

(c) A proximal opening defined in the proximal extension, wherein the proximal opening is sized to couple with an elongate tube, whereby the proximal opening allows liquid to flow into the lumen;

(d) A flow restricting structure associated with the bulb body, wherein the flow restricting structure includes a restricted configuration in which the flow restricting structure is configured to restrict a flow of fluid through the lumen such that the user must apply at least a first amount of negative pressure to increase the flow of the fluid; and

(e) At least one distal opening defined in the nozzle and in fluid communication with the lumen,

wherein the flow restricting structure can be the at least one distal opening.

2. The exercise device of claim 1, wherein the suction nozzle has an oval cross-sectional shape.

3. The exercise device of claim 1, wherein the flow restriction structure further comprises an unrestricted configuration configured to allow liquid to flow through the unrestricted configuration at a rate greater than the restricted configuration, wherein the flow restriction structure is forced into the unrestricted configuration after the user has applied at least a second amount of negative pressure, wherein the second amount is greater than the first amount.

4. The exercise device of claim 1, wherein the at least one distal opening is a slit defined in a distal end of a distal extension.

5. The exercise device of claim 4, wherein a length of the slit is substantially parallel to a cross-sectional width of the distal extension.

6. The exercise device of claim 4, wherein the slit includes a stress relief opening defined at each end of the slit.

7. The exercise device of claim 1, wherein the outer diameter of the central body is greater than the outer diameters of the distal extension and the proximal extension.

8. The exercise device of claim 1, wherein an outer diameter of the central body is smaller than an outer diameter of the distal extension and the proximal extension.

9. The exercise device of claim 1, wherein an outer diameter of the central body is substantially similar to an outer diameter of the distal extension and the proximal extension.

10. The exercise device of claim 1, wherein the flow restriction is disposed anywhere along the length of the lumen.

11. The exercise device of claim 10, wherein the flow restricting structure comprises a narrow section defined within the lumen, wherein the narrow section has a narrower diameter than any other portion of the lumen.

12. An oropharyngeal exercise system, the system comprising:

(a) A liquid container;

(b) A cap removably coupled to the liquid container, the cap including a bulb receiving opening defined therein; and

(c) A pump bulb removably positioned in the bulb receiving opening, the pump bulb including:

(i) A bulb body, the bulb body comprising:

(A) A suction nozzle;

(B) A proximal extension; and

(C) A central body disposed between the suction nozzle and the proximal extension, wherein an outer diameter of the central body is greater than an outer diameter of the suction nozzle and the proximal extension;

(ii) A lumen defined within the bulb body;

(iii) At least one distal opening defined in a distal extension and in fluid communication with the lumen, wherein the opening is configured to restrict liquid flow out of the lumen; and

(iv) A proximal opening defined in the proximal extension, wherein the proximal opening is larger than the at least one distal opening, whereby the proximal opening allows liquid to flow into the lumen.

13. The exercise system of claim 12, wherein the center body includes an attachment structure, wherein the attachment structure is configured to be sealingly coupleable with the bulb receiving opening.

14. The exercise system of claim 12, further comprising an elongated tube removably positioned within the proximal opening.

15. The exercise system of claim 12, wherein the at least one distal opening is a slit defined in a distal end of the suction nozzle.

16. An oropharyngeal exercise device, the device comprising:

(a) A bulb body, the bulb body comprising:

(i) A distal extension;

(ii) A proximal extension; and

(iii) A central body disposed between the distal extension and the proximal extension;

(b) A lumen defined within the bulb body such that the lumen is defined within the distal extension, the proximal extension, and the central body;

(c) At least one distal opening defined in the distal extension and in fluid communication with the lumen, wherein the at least one distal opening comprises:

(i) In a first restricted configuration, the first configuration is, the first restricted configuration is configured to restrict liquid flow through the first restricted configuration; and

(ii) A second open configuration configured to allow liquid to flow through the second open configuration at a greater rate than the first restricted configuration,

wherein the at least one distal opening is forced into the second open configuration when a user has applied a predetermined amount of compressive force to an outer wall of the distal extension via the user's tongue;

(d) A proximal opening defined in the proximal extension, wherein the proximal opening is larger than the at least one distal opening, whereby the proximal opening allows liquid to flow into the lumen.

17. The exercise device of claim 16, wherein the distal extension has an oval cross-sectional shape.

18. The exercise device of claim 16, wherein the distal extension is a mouthpiece configured for insertion into a mouth of a user.

19. The exercise device of claim 16, wherein the at least one distal opening is defined in a distal end of the distal extension.

20. The exercise device of claim 16, wherein the at least one distal opening includes a plurality of distal openings.